Austrian Multivessel Taxus-Stent Registry (AUTAX)

This study has been completed.

Sponsor:

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00738686

First received: August 19, 2008

Last updated: August 20, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 19, 2008

Last Updated Date

August 20, 2008

Start Date ^ICMJE

June 2004

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of MACCE, defined as all-cause death, nonfatal acute myocardial infarction (AMI) target vessel revascularization (TVR) and cerebrovascular event during the two-year clinical follow-up (FUP) [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00738686 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Break-down primary endpoints at the 2-year FUP, as the rate of TVR, non-fatal AMI, all-cause death, stroke and the composite of death and AMI [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Incidence of 30-days, 6-mo and 1-year MACCE [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Acute, subacute and late thrombosis rates [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Angiographic end-points as the binary restenosis rate per lesion (defined as diameters stenosis ≥ 50%), in-stent and proximal and distal in-lesion late lumen loss [ Time Frame: 6-month ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Austrian Multivessel Taxus-Stent Registry

Official Title ^ICMJE

Austrian Multivessel Taxus-Stent Registry

Brief Summary

The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel disease and multiple Taxus stent implantations in the "real world" stenting at 30 days, 6 and 12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to economic considerations, the secondary aim is to enhance experience in multivessel stenting with drug-eluting stents in order to improve short- and long-term outcomes of the patients with severe multiple coronary artery stenoses.

The objectives of the study are:

To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical follow-up after multivessel intervention with drug-eluting stents in a prospective patient cohort..
To determine the rate of in-stent restenosis, target lesion and target vessel revascularization (angiographic measures) 6 months in patients with multiple DESs in multiple lesions.
To investigate the clinical and angiographic outcomes after implantation of multiple DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal insufficiency) with known high restenosis and late complication rate.
To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Device: Intracoronary stent implantation

Taxus stent implantation in patients with multivessel coronary artery disease

Other Names:

Taxus Express
Taxus Liberte

Study Arm (s)

Experimental: 1

Single-arm study, no placebo or control group

Intervention: Device: Intracoronary stent implantation

Publications *

Gyöngyösi M, Christ G, Lang I, Kreiner G, Sochor H, Probst P, Neunteufl T, Badr-Eslam R, Winkler S, Nyolczas N, Posa A, Leisch F, Karnik R, Siostrzonek P, Harb S, Heigert M, Zenker G, Benzer W, Bonner G, Kaider A, Glogar D; AUTAX Investigators. 2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study. JACC Cardiovasc Interv. 2009 Aug;2(8):718-27.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

441

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

symptomatic coronary multivessel disease
possible percutaneous complete coronary revascularization
age >18 year
significant coronary lesion at least in 2 vessels

Exclusion Criteria:

acute myocardial infarction within 48 hours
contraindications to clopidogrel, aspirin, heparin and taxol
pregnancy or lack of protection against pregnancy or breast-feeding during the study
hemorrhagic diathesis
platelet count <100.000/ml3

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00738686

Other Study ID Numbers ^ICMJE

AUTAX

Has Data Monitoring Committee

Yes

Responsible Party

Helmut-Dietmar Glogar, Dept. Cardiology, Medical University of Vienna, Austria

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Helmut-Dietmar Glogar, MD FESC

Dept. Cardiology, Medical University of Vienna, Vienna, Austria

Information Provided By

Medical University of Vienna

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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